Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial

Abstract

BackgroundPancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic stones, it is still not complication-free. Just like endoscopic retrograde cholangiopancreatography (ERCP), pancreatitis is the most common complication. To date, nonsteroidal anti-inflammatory drugs (NSAIDs) have proven to be the only effective prophylactic medication for post-ERCP pancreatitis and the European, American and Japanese Society for Gastrointestinal Endoscopy guidelines have recommended prophylactic rectally administered indomethacin for all patients undergoing ERCP. Given the little research about effective prevention for post P-ESWL pancreatitis, we aim to determine whether rectally administered indomethacin can reduce post-ESWL-pancreatitis.Methods/designThe RIPEP study is a prospective, randomized, double-blinded, placebo-controlled trial. One thousand three hundred and seventy patients with chronic pancreatitis and pancreatic stones (>5 mm in diameter) treated with P-ESWL at Changhai Hospital will be randomly allocated to rectally administered indomethacin or placebo therapy before the procedure. The primary endpoint is the incidence of post-ESWL pancreatitis. Secondary endpoints include the severity of pancreatitis, occurrence rate of asymptomatic hyperamylasemia and other complications.DiscussionThe RIPEP trial is designed to show that rectally administered indomethacin reduces the development and severity of post-ESWL pancreatitis and benefits patients treated with P-ESWL.Trial registrationClinicalTrials.gov, ID: NCT02797067. Registered on 17 November 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2250-7) contains supplementary material, which is available to authorized users.

Chronic Use of Statins and Their Effect on Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

“…Concerning pharmaco-prevention modalities, to date, non-steroidal anti-inflammatory drugs (NSAIDs) are the only medications to be effective in PEP prevention (Cote and Elmunzer, 2016 ; Chandrasekhara et al, 2017 ). Furthermore, evidence is emerging that rectal administration of NSAIDs such as indomethacin or diclofenac just before or after ERCP might reduce the risk and severity of post-procedure pancreatitis (Dumonceau et al, 2014 ; Qian et al, 2017 ). According to the updated European Society of Gastrointestinal Endoscopy (ESGE) guidelines for PEP prevention, there is no evidence that drugs such as corticosteroids, antioxidants, heparin, sphincter of Oddi pressure reducers, and/or anti-inflammatory drugs (other than indomethacin and diclofenac) can effectively reduce the risk of PEP (Dumonceau et al, 2014 ).…”

Comparison of the therapeutic methods (pharmacologic and nonpharmacologic) on prevention of post-ERCP pancreatitis: A systematic review and meta-analysis

“…[9][10][11] Moreover, the administration of non-steroidal anti-inflammatory drugs (NSAIDs) like indomethacin and diclofenac or hydration with lactated Ringer's solution (LR) or normal saline are recommended for preventing PEP. 8,[12][13][14][15][16][17] In a concluding systematic review and meta-analysis, Elmunzer et al showed a lower risk of PEP with the administration of diclofenac and indomethacin. 18 Additionally, pancreatic stent placement (PSP), was first introduced in the United States in the late 1990s, as a common clinical practice and extended as an effective preventing tool for PEP in high-risk cases.…”